Waldemar Link recalled 7 Endo-Model Replacement Plateau devices distributed worldwide, including New Jersey. The recall targets an implant component where a bushing could detach from the screw shaft after a longitudinal fracture. Healthcare providers and patients should stop using the device and follow recall instructions provided by the manufacturer.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: Letter
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Endo-Model Replacement Plateau is an orthopedic implant component used in surgical fixation. It is intended to provide stability in the implanted construct when used by trained surgeons.
If the bushing detaches from the screw shaft due to a longitudinal fracture, the implant may lose integrity, possibly requiring surgical intervention.
This recall is not described as part of a broader industry pattern in the provided information.
Patients could require additional surgery. Healthcare providers must assess device stability and determine whether replacement or repair is necessary.
Recall letter from Waldemar Link. FDA recall page Z-1516-2026.
Refund or replacement timelines are determined by the manufacturer; typical timelines can vary widely in medical device recalls.
Keep the recall notice, device identifiers, medical records, and all correspondence with the manufacturer.
Model numbers and identifiers include Item Number 15-2836/11 and UDI-DI 04026575316571. Serial/Lot Numbers affected include 250623/3643, 250623/3644, 250623/3645, 250623/3646, 250623/3648, 250812/2812, and 250812/2811. Recall date: 2026-01-12. Distribution: Worldwide, including US NJ and the countries Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Quantity: 7 units (OUS only). Manufacturer: Waldemar Link GmbH & Co. KG. Status: ACTIVE.
No injuries or incidents have been reported.
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Waldemar Link recalled 7 Endo-Model Replacement Plateau implants worldwide, including a NJ distribution. The defect could cause the bushing to detach from the screw shaft after a longitudinal fracture. Health providers should stop use and await recall instructions.